Urinary incontinence is a public health issue which affects more than 13 million women in the USA only. There exist different types of urinary incontinence in women, such as urge incontinence, stress incontinence and mixed incontinence. Women having urge incontinence suffer from at least some unwanted leakage caused by urgency. The focus herein is however not urge incontinence but urinary stress incontinence, often also just called stress incontinence. Of the number of women suffering from urinary incontinence about half of them suffer from stress incontinence. Urinary stress incontinence is mainly caused by connective tissue laxity or damage in the vagina or its supporting ligaments. The background to urinary stress incontinence and its origin may be described by the Integral Theory (An integral theory and its method for the diagnosis and management of female urinary incontinence, Petros P E, Ulmsten U I, Scand J Urol Nephrol Suppl, 1993; 153:1-93), which states that connective tissue damage to the 3 zones of the Integral System, which encompasses all three pelvic organs, bladder, vagina and ano-rectum, is the ultimate cause of prolapse and dysfunction in these organs. In other words, stress incontinence may be caused by a defect function of the tissue or ligaments connecting the urethra and vaginal wall with the pelvic muscles and pubic bone. Examples of women suffering from stress incontinence are such having experienced complicated deliveries, such as disproportion, big child or instrumental delivery. However, genetic factors may also be of importance and may cause these defect functions.
Today there exist surgical methods supported by the knowledge of the Integral Theory. For example, U.S. Pat. No. 5,899,909 discloses a surgical method for restoration of incontinence, the today called TVT (tension free vaginal tape) method which is a method effectively preventing and eliminating stress incontinence. U.S. Pat. No. 5,899,909 discloses a method comprising the steps of passing a tape into the body via the vagina first at one end thereof and then at the other end thereof at one side and the other, respectively, of urethra to form a loop around urethra, located between urethra and the upper vaginal wall, extending said tape over the pubic bone and through the abdominal wall, the ends of the tape being available outside the abdominal wall, tightening said strap at said ends, and leaving the tape implanted in the body. The tape is left permanently in the body to provide itself, as an artificial ligament, the reinforcement of the tissue required in order to restore the urinary incontinence, and/or to provide said reinforcement by the development of fibrous tissue. A surgical instrument for performing the method according to U.S. Pat. No. 5,899,909 is also disclosed.
The method disclosed according to U.S. Pat. No. 5,899,909 works very well. However, it is a surgical method and as such it is not available for all women in need of help to reduce or eliminate stress incontinence problems. Due to the fact that stress incontinence in women is an extensive, widely spread problem all around the world, it is firstly not possible to treat everyone in need of a surgical treatment. Secondly, in several countries, such as China and India, the possibility of receiving a TVT surgery is very limited. Moreover, many women suffering from stress incontinence prefer conservative treatment or are not suitable for TVT surgery, for instance due to high age. Furthermore, in countries not having free medical service, or with only parts of that service being free, there will be many women having this problem but not the financial means to pay for a TVT surgery.
There exist today different devices with the purpose of alleviating incontinence in women. U.S. Pat. No. 6,739,340 discloses a device for prevention of involuntary urination. The device comprises a body for arrangement in the vagina for compressive action on and support of the neck of the bladder and optionally the urethra. The body has a substantially elongated shape with a longitudinal axis extending, in the intended direction of insertion, from a proximal to a distal end and is made from a compressive and elastically deformable material. The body comprises at least one part protruding from the outer surface of the body which is said to provide at least one pressure area for contact with the neck of the bladder and optionally the urethra.
U.S. Pat. No. 6,645,137 discloses a vaginal insert having a flexible body either in the form of a belt or a split cylinder. In either case, the insert may be coiled into a coiled state. The body is said to have a reduced diameter when coiled and exhibits a resilient bias toward uncoiling and expanding in diameter from the coiled state. When the insert is inserted into the vagina of a patient, it is said to expand and press against the vaginal wall, such as for treating incontinence. A medicament may be combined with the insert that is introduced to the patient through contact with the insert, such as for treating incontinence with a drug as well as pressure. The belt-type body may incorporate mating ridges and grooves to keep the insert in a cylindrical shape. Latch elements may be incorporated on the insert to support the insert in an expanded, partially uncoiled state.
There are disadvantages with the known vaginal devices disclosed above. Firstly, none of these devices are securely fixated inside of the vagina during normal use. When women move or for instance exercise there exists a great risk for movement of these devices inside the vagina. Another circumstance when this problem may be extensive is during a sneeze when the pressure power inside of the vagina is very large. This may also render the vaginal devices being pushed down towards the opening of the vagina. These cases of movement of the vaginal devices inside of the vagina render the pressing elements, that is the at least one protruding part in U.S. Pat. No. 6,739,340 and the protruding coils in U.S. Pat. No. 6,645,137, of the vaginal devices to press on the wrong site of the vaginal wall or urethra. In those cases these vaginal devices have only limited effect or no effect at all with respect to the prevention of stress incontinence. Moreover, both of these devices may be harmful for the patient or be perceived as unpleasant to use. This is caused by the designs of the pressing elements of these vaginal devices.
One object of the present invention is to provide a vaginal device for the prevention of incontinence of the type called urinary stress incontinence, which vaginal device may function as an alternative for a patient not suitable for or one does not want to undergo a TVT surgery and which vaginal device solves the problems described above with up to now known vaginal devices.